Levetiracetam 250 mg. 30 tablets

What is Levetiracetam Accord and what it is used
Levetiracetam Accord is an antiepileptic medicine (a medicine to treat seizures in epilepsy).

Levetiracetam Accord is used:
alone in adults and adolescents 16 years and older with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalization;
in addition to other antiepileptic medicines to treat:
partial onset seizures with or without generalization in adults, adolescents, children and infants of one or more months;
myoclonic seizures in adults and adolescents 12 years and older with juvenile myoclonic epilepsy;
primary generalized tonic-clonic seizures in adults and adolescents 12 years and older with idiopathic generalized epilepsy.

2. What you need to know before you take Levetiracetam Accord
Do not take Levetiracetam Accord:
If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
Talk to your doctor before taking Levetiracetam Accord:
If you have kidney problems, follow your doctor's instructions. Your doctor may decide that your dose should be adjusted;
If you notice any slowdown or unexpected puberty development of your child, please tell your doctor;
If you notice an increase in seizure severity (eg increased number), please tell your doctor;
A small number of people being treated with anti-epileptics such as Levetiracetam Accord have had thoughts of harming or killing themselves. If you have symptoms of depression and / or suicidal thoughts, please contact your doctor.
Other medicines and Levetiracetam Accord
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Levetiracetam Accord with food, drink and alcohol
You may take Levetiracetam Accord with or without food. As a precaution, do not take Levetiracetam Accord with alcohol.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine. If you are pregnant or think you are pregnant, please tell your doctor.
Levetiracetam Accord should not be used during pregnancy unless clearly necessary. Can not completely exclude the risk of birth defects for your unborn child. Levetiracetam Accord studies in animals have shown adverse reproductive effects at doses which are significantly higher than those that you need to control your seizures.
Breastfeeding is not recommended during treatment.

Driving and using machines
Levetiracetam Accord may affect your ability to drive and use machines as Levetiracetam Accord can cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. Do not use any tools or machines until it is established that your ability to perform such activities is not affected.

Levetiracetam Accord 750 mg film-coated tablets contain sunset yellow FCF (E110)
Sunset yellow coloring agent may cause allergic reactions.
Other types of Levetiracetam Accord tablets do not contain this ingredient.

3. How to take Levetiracetam Accord
Always take this medicine exactly as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
Levetiracetam Accord should be taken twice daily, once in the morning and once in the evening, at the same time each day.
Take the number of tablets that you have been told your doctor.
monotherapy
Adults and adolescents (16 years and over):
Usual dose: between 1000 mg and 3000 mg each day.
When you initially start taking Levetiracetam Accord, your doctor will prescribe a lower dose for 2 weeks before giving you the lowest general dose.
For example: if your daily dose is 1000 mg, you must take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Add-on therapy
Adults and adolescents (12-17 years) weighing 50 kg or more:
Usual dose: between 1000 mg and 3000 mg each day.
For example: if your daily dose of 1000 mg, you must take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Dosage in infants (6-23 months), children (2-11 years) and adolescents (12-17 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate form of Levetiracetam Accord according to age, weight and dosage.
Oral solution is more suitable form for infants and children under six years.
Usual dose: between 20 mg per kg body weight and 60 mg per kg of body weight each day.
For example: if the usual dose is 20 mg per kg body weight every day, you need to give your child weighing 25 kg, 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening.

Dosage in infants (1 month to less than 6 months):
Oral solution is more suitable form for use in infants.

Route of administration:
Swallow the tablets Levetiracetam Accord with a sufficient amount of liquid (eg a glass of water).

Duration of treatment:
Levetiracetam Accord is used as a chronic treatment. You should take Levetiracetam Accord as long as you advise your doctor.
Do not stop taking Levetiracetam Accord without advice from your doctor as this could increase your seizures. If your doctor decides to stop your treatment with Levetiracetam Accord, he will explain how to gradually reduce intake of Levetiracetam Accord.
If you take more than the amount of Levetiracetam Accord:
Possible side effects of an overdose of levetiracetam are sleepiness, agitation, aggression, attention deficit, respiratory depression and coma.
Tell your doctor if you take more tablets. Your doctor will take the best possible measures overdose.

If you miss a dose of Levetiracetam Accord:
Tell your doctor if you have missed one or more doses.
Do not take a double dose to make up for a missed tablet.

If you stop taking Levetiracetam Accord:
If stopping treatment, as with other antiepileptic drugs intake of Levetiracetam Accord should be discontinued gradually to avoid an increase of seizures.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them.
Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of treatment or when increasing the dose. These effects are expected to decrease over time.

Very common: may affect more than 1 in 10 people:
nasopharyngitis;
somnolence (sleepiness), headache.
Common: may affect up to 1 in 10 people:
anorexia (loss of appetite);
depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
convulsion, disturbance in balance (tripping), dizziness (sensation of unsteadiness), lethargy, tremor (involuntary shaking);
vertigo (feelings of dizziness);
cough;
abdominal pain, diarrhea, dyspepsia (digestive disorder), vomiting, nausea;
rash;
asthenia / fatigue (tiredness).
Uncommon: may affect up to 1 in 100 people:
decreased platelet count, decreased leukocyte;
weight reduction, weight gain;
suicide attempt and suicidal thoughts, psychotic disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability / mood swings, anxiety;
amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination / ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
diplopia (double vision), blurred vision;
deviation from normal values the results of examination of the liver;
hair loss, eczema, pruritus;
muscular weakness, myalgia (muscle pain);
injury.
Rare: may affect up to 1 in 1000 people:
infection;
reduced number of all types of blood cells;
severe hypersensitivity reactions (DRESS);
namalyanie the concentration of sodium in the blood;
suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, unable to concentrate);
uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
pancreatitis;
liver failure;
skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin , particularly around the mouth, nose, eyes and genitals (Stevens-Johnson) and a more severe form, causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).
If you get any side effects, contact your doctor or pharmacist. This includes any possible effects not listed in this leaflet.

Adverse event reporting
If you get any side effects, contact your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects, you can do your bit for getting more information on the safety of this medicine.

5. How to store Levetiracetam Accord
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month
This medicine does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Levetiracetam Accord:
Active substance or: levetiracetam.
Each tablet contains 250 mg, 500 mg, 750 mg or 1000 mg of levetiracetam.

Core components of the tablet:
croscarmellose sodium, povidone K-30, colloidal anhydrous silica, magnesium stearate (E470b).
Film Coating:
250 mg: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc;
500 mg: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E172);
750 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172), sunset yellow FCF (E110);
1000 mg: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc.
Levetiracetam Accord looks like and contents of the pack
250 mg:
White to off-white, oval, biconvex film-coated tablet debossed with "L 64" and breakline on one side and plain on the other side.